Trial Outcomes & Findings for A Study of the Efficacy and Safety of MK2578 for the Treatment of Anemia in Patients With Kidney Disease (MK2578-003-AM03-EXT12) (NCT NCT00924781)
NCT ID: NCT00924781
Last Updated: 2015-11-02
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
4 weeks
Results posted on
2015-11-02
Participant Flow
Participants were recruited from 46 centers (9 centers in Bulgaria, 27 in United States, 3 in Romania, 4 in Italy, and 3 in Poland).
At randomization, participants received either MK2578 or matching placebo on Day 1 and crossed over to the alternate treatment at the next dialysis treatment on Day 3.
Participant milestones
| Measure |
MK2578 1mcg/600 U or 1 mcg/350 U QW
MK2578 was administered intravenously (IV) QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 Units (U) of Epogen (epoetin alfa) received per week at Baseline.
|
MK2578 1mcg/600 U or 1 mg/350 U QM
MK2578 was administered IV QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 Units (U) of Epogen (epoetin alfa) or 350 units of Epogen (epoetin alpha) received per week at Baseline.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
19
|
|
Overall Study
COMPLETED
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
12
|
10
|
Reasons for withdrawal
| Measure |
MK2578 1mcg/600 U or 1 mcg/350 U QW
MK2578 was administered intravenously (IV) QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 Units (U) of Epogen (epoetin alfa) received per week at Baseline.
|
MK2578 1mcg/600 U or 1 mg/350 U QM
MK2578 was administered IV QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 Units (U) of Epogen (epoetin alfa) or 350 units of Epogen (epoetin alpha) received per week at Baseline.
|
|---|---|---|
|
Overall Study
Study terminated by sponsor
|
12
|
10
|
Baseline Characteristics
A Study of the Efficacy and Safety of MK2578 for the Treatment of Anemia in Patients With Kidney Disease (MK2578-003-AM03-EXT12)
Baseline characteristics by cohort
| Measure |
MK2578 1mcg/600U QW
n=16 Participants
MK2578 IV administered QW.
|
MK2578 1mcg/600U QM
n=15 Participants
MK2578 IV administered QM.
|
MK2578 1mcg/350U QW
n=4 Participants
MK2578 IV administered QW.
|
MK2578 1mcg/350U QM
n=4 Participants
MK2578 IV administered QM.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 14.29 • n=5 Participants
|
51.7 years
STANDARD_DEVIATION 10.22 • n=7 Participants
|
58.0 years
STANDARD_DEVIATION 8.91 • n=5 Participants
|
60.5 years
STANDARD_DEVIATION 4.51 • n=4 Participants
|
51.0 years
STANDARD_DEVIATION 12.30 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Full analysis set
Outcome measures
| Measure |
MK2578 1mcg/600U QW
n=16 Participants
MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 Units (U) of Epogen (epoetin alfa) received per week at Baseline.
|
MK2578 1mcg/600U QM
n=14 Participants
MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
|
MK2578 1mcg/350U QW
n=1 Participants
MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
|
MK2578 1mcg/350U QM
n=1 Participants
MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
|
|---|---|---|---|---|
|
Change From Baseline in Hemoglobin (Hg) Level at Week 4
|
-0.6 g/dL
Standard Deviation 0.8
|
-0.7 g/dL
Standard Deviation 1.0
|
-1.0 g/dL
Standard Deviation NA
Only one patient was included in this analysis, thus the SD is not calculated.
|
-1.0 g/dL
Standard Deviation NA
Only one patient was included in this analysis, thus the SD is not calculated.
|
PRIMARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
MK2578 1mcg/600U QW
n=16 Participants
MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 Units (U) of Epogen (epoetin alfa) received per week at Baseline.
|
MK2578 1mcg/600U QM
n=15 Participants
MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
|
MK2578 1mcg/350U QW
n=4 Participants
MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
|
MK2578 1mcg/350U QM
n=4 Participants
MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
|
|---|---|---|---|---|
|
Number of Participants With Composite Events of Death, Myocardial Infarction (MI), and Cerebrovascular Accident (CVA)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
MK2578 1mcg/600U QW
n=16 Participants
MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 Units (U) of Epogen (epoetin alfa) received per week at Baseline.
|
MK2578 1mcg/600U QM
n=15 Participants
MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
|
MK2578 1mcg/350U QW
n=4 Participants
MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
|
MK2578 1mcg/350U QM
n=4 Participants
MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
|
|---|---|---|---|---|
|
Number of Participants With Composite Events of Transfusion-Related Adverse Experiences
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
MK2578 1mcg/600U QW
n=16 Participants
MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 Units (U) of Epogen (epoetin alfa) received per week at Baseline.
|
MK2578 1mcg/600U QM
n=15 Participants
MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
|
MK2578 1mcg/350U QW
n=4 Participants
MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
|
MK2578 1mcg/350U QM
n=4 Participants
MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
|
|---|---|---|---|---|
|
Number of Participants With Composite Events of Infusion Reactions
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
MK2578 1mcg/600U QW
n=16 Participants
MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 Units (U) of Epogen (epoetin alfa) received per week at Baseline.
|
MK2578 1mcg/600U QM
n=15 Participants
MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
|
MK2578 1mcg/350U QW
n=4 Participants
MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
|
MK2578 1mcg/350U QM
n=4 Participants
MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
|
|---|---|---|---|---|
|
Number of Participants With Events of Death, MI, CVA, Peripheral Vascular Thromboses, Vascular Access Thrombosis, Congestive Heart Failure (CHF), Hypertension, Seizure, or Pure Red Cell Aplasia
Vascular access thrombosis
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Events of Death, MI, CVA, Peripheral Vascular Thromboses, Vascular Access Thrombosis, Congestive Heart Failure (CHF), Hypertension, Seizure, or Pure Red Cell Aplasia
Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Events of Death, MI, CVA, Peripheral Vascular Thromboses, Vascular Access Thrombosis, Congestive Heart Failure (CHF), Hypertension, Seizure, or Pure Red Cell Aplasia
MI
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Events of Death, MI, CVA, Peripheral Vascular Thromboses, Vascular Access Thrombosis, Congestive Heart Failure (CHF), Hypertension, Seizure, or Pure Red Cell Aplasia
CVA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Events of Death, MI, CVA, Peripheral Vascular Thromboses, Vascular Access Thrombosis, Congestive Heart Failure (CHF), Hypertension, Seizure, or Pure Red Cell Aplasia
Peripheral vascular thromboses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Events of Death, MI, CVA, Peripheral Vascular Thromboses, Vascular Access Thrombosis, Congestive Heart Failure (CHF), Hypertension, Seizure, or Pure Red Cell Aplasia
CHF
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Events of Death, MI, CVA, Peripheral Vascular Thromboses, Vascular Access Thrombosis, Congestive Heart Failure (CHF), Hypertension, Seizure, or Pure Red Cell Aplasia
Hypertension
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Events of Death, MI, CVA, Peripheral Vascular Thromboses, Vascular Access Thrombosis, Congestive Heart Failure (CHF), Hypertension, Seizure, or Pure Red Cell Aplasia
Seizure
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Events of Death, MI, CVA, Peripheral Vascular Thromboses, Vascular Access Thrombosis, Congestive Heart Failure (CHF), Hypertension, Seizure, or Pure Red Cell Aplasia
Pure red cell aplasia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Immunogenicity assays for antibodies to MK2578 were not performed due to early study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full analysis set; due to study termination participants in the MK2578 1mcg/350U QW and MK2578 1mcg/350U QM were not analyzed.
Outcome measures
| Measure |
MK2578 1mcg/600U QW
n=6 Participants
MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 Units (U) of Epogen (epoetin alfa) received per week at Baseline.
|
MK2578 1mcg/600U QM
n=11 Participants
MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
|
MK2578 1mcg/350U QW
MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
|
MK2578 1mcg/350U QM
MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
|
|---|---|---|---|---|
|
Change From Baseline in Hg Level at Week 12
|
-0.1 g/dL
Standard Deviation 1.4
|
-0.5 g/dL
Standard Deviation 1.4
|
—
|
—
|
Adverse Events
MK2578 QW
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
MK2578 QM
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MK2578 QW
n=20 participants at risk
MK2578 IV administered once weekly.
|
MK2578 QM
n=19 participants at risk
MK2578 IV administered once every 4 weeks.
|
|---|---|---|
|
Cardiac disorders
Acute mycoardial infarction
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
Other adverse events
| Measure |
MK2578 QW
n=20 participants at risk
MK2578 IV administered once weekly.
|
MK2578 QM
n=19 participants at risk
MK2578 IV administered once every 4 weeks.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
|
Cardiac disorders
Tachycardia
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
|
Endocrine disorders
Adrenal cyst
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distention
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Asthenia
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Oedema peripheral
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Bacterial disease carrier
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Gastroenteritis viral
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Injury, poisoning and procedural complications
Haemodialysis-induced symptom
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Blood pressure increased
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Ultrasound pelvis abnormal
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.0%
1/20 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Renal and urinary disorders
Renal vein thrombosis
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Reproductive system and breast disorders
Menorrhagia
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
|
Vascular disorders
Arterial occlusive disease
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
|
Vascular disorders
Brachiocephalic vein stenosis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • Number of events 1
|
0.00%
0/19
|
|
Vascular disorders
Hypotension
|
0.00%
0/20
|
5.3%
1/19 • Number of events 1
|
Additional Information
Senior Vice President, Global Clinical Development
Merck, Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER